Ropidoxuridine and Whole Brain Radiation Therapy in Treating Patients With Brain Metastases (NCT02993146) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Ropidoxuridine and Whole Brain Radiation Therapy in Treating Patients With Brain Metastases
United States11 participantsStarted 2017-05-08
Plain-language summary
This phase I trial studies the side effects and best dose of ropidoxuridine when given together with whole brain radiation therapy in treating patients with cancer that has spread to the brain (brain metastases). Ropidoxuridine may help whole brain radiation therapy work better by making cancer cells more sensitive to the radiation therapy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically confirmed malignancy with brain metastases and are being recommended palliative WBRT
* Life expectancy of greater than 2 months to allow completion of study treatment and assessment of dose-limiting toxicity
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count \>= 1,000/mcL
* Platelets \>= 100,000/mcL
* Calculated creatinine clearance \>= 45 mL/min/1.73 m\^2
* Total bilirubin:
* If no known liver metastases: total bilirubin \< 1.5 x institutional upper limit of normal (ULN)
* If known liver metastases, then: total bilirubin \< 2.5 x ULN
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]):
* If no known liver metastases: AST/SGOT and ALT/SGPT both \< 2 x ULN
* If known liver metastases, then: AST/SGOT and ALT/SGPT both \< 5 x ULN
* Human immunodeficiency virus (HIV) positive (+) patients with CD4 counts \>= 250 cells/mm\^3 on anti-viral therapy are eligible for the study
* Negative urine or serum pregnancy test result for females of child bearing potential only; Note: The effects of IPdR on the developing human fetus are unknown; for this reason and because radiation therapy is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier meth…
What they're measuring
1
Number of Participants Experiencing a Dose Limiting Toxicity